CT COMPARE: CT Coronary Angiography to Measure Plaque Reduction

• Status: Active, not recruiting
• Trial end date: 2023-05-04
• Target enrollment: 0
• Participant gender: All

Summary

Background:

Coronary artery disease causes plaque in arteries. This can cause stroke or heart disease. Drugs called statins might shrink plaque. Researchers want to study how CT scanning can determine if an individual s arterial plaque has decreased while taking statins.

Objectives:

To measure the change in coronary artery plaque volume in people treated with high-intensity statin therapy using CT and MRI scans. To study the metabolic activity of plaque in arteries. To determine how well plaque measurements from heart CT scans can be replicated.

Eligibility:

Men ages 40-75 and women ages 40-75 who are good candidates for statin treatment

Design:

Visit 1: participants will be screened with:

• Medical history

• Blood tests

• Heart MRI and CT scan: An IV inserted into an arm or hand vein removes blood and injects contrast, and medicine if needed. Participants lie on a table that slides into a machine that takes pictures of the body. For the CT scan, if their heart rate is too high, they get medicine to lower it. They breathe in a special way, holding their breath for 5 seconds.

Participants will begin high-intensity statin treatment.

Participants will have 7 more visits over 3 years. All visits include blood tests and medication review. Some may also include:

• Statin treatment adjustment

• CT scan

• MRI scan

• Physical exam

Participants may join the PET Substudy. This includes 5 more visits during the study. These include:

• Getting an IV in an arm vein

• Blood tests

• PET scans: They fast 12 hours before.

Participants may join the Reproducibility Substudy if they had a slow heart rate during their first CT scan. This includes 1 additional heart CT scan 4 weeks later.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health Clinical Center (CC)
• Treatments: Atorvastatin; Atorvastatin Calcium; Rosuvastatin Calcium

Criteria

• INCLUSION CRITERIA:

A. Men greater than or equal to 40 and less than or equal to 75 years of age; women greater than or equal to 40 and less than or equal to 75 years of age

B. Willing to travel to the NIH for follow-up visits.

C. Willing to start or modify statin therapy.

D. Able to understand and sign informed consent.

E. Eligible for primary prevention statin therapy

1. Eligible for at least moderate intensity statin according to 2013 ACC/AHA GRCR (i.e., greater than or equal to 5% 10 year cardiovascular risk, https://my.americanheart.org/professional/StatementsGuidelines/Prevention-Guidelines_U CM_457698_SubHomePage.jsp) OR

2. low (<5%) 10 year cardiovascular risk per 2013 ACC/ AHA and with coronary artery calcium score greater than or equal to 300 Agatston units or greater than or equal to 75 percentile for age, sex, and ethnicity determined per MESA study

(http://www.mesa-nhlbi.org/calcium/input.aspx).

EXCLUSION CRITERIA:

A. Allergy or prior clinically relevant adverse reaction to Rosuvastatin (does not include minor muscle pain).

B. High intensity statin treatment for more than 90 days prior to enrollment

C. LDL greater than or equal to 190 mg/ml

D. Physician-diagnosed heart attack

E. Physician-diagnosed stroke or TIA

F. Physician-diagnosed heart failure

G. Having undergone procedures related to cardiovascular disease (CABG, angioplasty, valve replacement, pacemaker or defibrillator implantation, any surgery on the heart or arteries)

H. Active treatment for cancer

I. Prior hypersensitivity reaction to iodinated contrast injection

J. Known hyperthyroidism.

K. Acute renal failure, renal transplant, dialysis and renal failure clinically diagnosed.

L. History of liver transplant or severe liver disease or unexplained elevation of baseline ALT>3x upper limit of normal

M. Pregnancy and nursing

N. Mental, neurologic or social condition preventing understanding of the rationale, procedures, risks and potential benefits associated with the trial.

O. Any other conditions that precludes safety for MRI and/or CT imaging per the researcher s evaluation.

P. Individuals with hemoglobinopathies or severe asthma.

Q. Severe renal excretory dysfunction, estimated glomerular filtration (eGFR) rate < 30 mL/min/1.73m2 body surface area according to the Modification of Diet in Renal Disease criteria Glomerular filtration rate will be estimated using the MDRD 2005 revised study formula: eGFR (mL/min/1.73m2) = 175 x (standardized serum creatinine)-1.154 x (age)-0.203 x 0.742 (if the subject is female) or x 1.212 (if the subject is black)